The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Smartlock Hybrid Mmf System.
| Device ID | K122313 |
| 510k Number | K122313 |
| Device Name: | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM |
| Classification | Plate, Bone |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Rob Yamashita |
| Correspondent | Rob Yamashita Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540732064 | K122313 | 000 |
| 04546540732040 | K122313 | 000 |
| 34546540732089 | K122313 | 000 |
| 34546540732072 | K122313 | 000 |
| 34546540732058 | K122313 | 000 |
| 34546540732034 | K122313 | 000 |